Adult Rheumatoid Arthritis (RA): ORENCIA® (abatacept) is a prescription medicine that reduces signs and symptoms in adults with moderate to severe RA, including those who have not been helped enough by other medicines for RA. ORENCIA may prevent further damage to your bones and joints and may help your ability to perform daily activities. In adults, ORENCIA may be used alone or with other RA treatments other than tumor necrosis factor (TNF) antagonists.

Juvenile Idiopathic Arthritis (JIA): ORENCIA reduces signs and symptoms in patients 2 years of age and older with moderate to severe polyarticular JIA. ORENCIA may be used alone or with methotrexate (MTX).

Adult Psoriatic Arthritis (PsA): ORENCIA is a prescription medicine that reduces signs and symptoms in adults with active Psoriatic Arthritis (PsA). In adults, ORENCIA may be used alone or with other PsA treatments.

What is Moderate to Severe Rheumatoid Arthritis (RA)
and How Does
ORENCIA® (abatacept) Work?

ORENCIA is an RA
medication that works by targeting a source
of RA early in the inflammation process

Explore the science behind ORENCIA and discover how it works in your body.

What is RA, and what
causes it?

RA is an autoimmune disease, meaning your immune system becomes overactive and mistakenly attacks the healthy tissues in your own body. In RA, a key target of the overactive immune system is the lining of the joints, also known as the synovium.

The exact cause of RA is unknown. RA may be influenced by many risk factors, including:

Genes

Infection

Hormonal
changes

Environmental
factors

Symptoms

What’s happening on the outside

Moderate to severe RA can cause symptoms such as joint pain and swelling. RA can be very different for each person. Because RA affects the joints in your body, it can have many symptoms, including:

Joint pain

Reduced mobility

Difficulty with daily activities, like:

Getting out of bed

Getting dressed

Opening a jar

Climbing stairs

Science

What’s happening on the inside

The pain and swelling occurs because the lining of your joint, called the synovium, becomes swollen or inflamed. The synovium is an important part of the capsules that support and protect your joints. Lining the inside of the capsules, a healthy synovium produces fluid that lubricates and nourishes your joints. RA affects joints that have a synovium, such as fingers, knees, and hips.

Selected Important Facts about ORENCIA

Serious side effects

Serious side effects are those that may require medical treatment or hospitalization, cause permanent damage, or be life-threatening or sometimes even fatal. Talk to your healthcare provider about any concerns you may have.

• Infections. ORENCIA can make you more likely to get infections or make the infections that you have worse. In some cases, these infections have been fatal. Symptoms of an infection include:

• Fever

• Cough

• Warm, red, or painful skin

• Feeling very tired

• Flu-like symptoms

• Fever

• Cough

• Warm, red, or painful skin

• Feeling very tired

• Flu-like symptoms

Call your healthcare provider right away if you feel sick or have any of the symptoms of an infection.

Please read the Important Facts About ORENCIA below, including other serious side effects.

Important Facts About ORENCIA® (abatacept)

This is a summary of important information that you need to know in order to take ORENCIA safely. Work with the rheumatologist to make the treatment suitable and safe for you or your loved one.

Look out for the following icons as you read:

Talk to your rheumatologist

Call a healthcare provider right away

Helpful information to remember

What is ORENCIA?

ORENCIA (abatacept) is a prescription biologic medicine for:

Adult Rheumatoid Arthritis (RA)

ORENCIA is used to reduce signs and symptoms of moderate to severe Rheumatoid Arthritis (RA) in adults 18 years and older. Taking ORENCIA may prevent further damage to your bones and joints, and may help your ability to perform daily activities. ORENCIA may help those who are not getting the results they need with other medicines for RA.

In adults, ORENCIA may be used alone or with other RA treatments, but should not be used with TNF-blockers (also called Tumor Necrosis Factor antagonists). TNF-blockers are a type of RA medication, and include such treatments as Enbrel® (etanercept), Humira® (adalimumab), and Remicade® (infliximab).

Juvenile Idiopathic Arthritis (JIA)

ORENCIA is used to reduce signs and symptoms of moderate to severe polyarticular JIA in patients 2 years of age and older. ORENCIA may be used alone or with methotrexate (MTX).

Adult Psoriatic Arthritis (PsA)

ORENCIA is used to reduce signs and symptoms of active Psoriatic Arthritis (PsA) in adults 18 years and older. In adults, ORENCIA may be used alone or with other PsA treatments.

ORENCIA is for adults 18 years and older with moderate to severe RA.

ORENCIA is for patients 2 years of age and older with moderate to severe polyarticular JIA.

ORENCIA is for adults 18 years and older with active PsA.

ORENCIA should not be used with TNF-blockers.

ORENCIA has not been studied in children under 2 years of age.

ORENCIA has not been studied in children for uses other than JIA.

ORENCIA is available in two forms:

ORENCIA intravenous (IV) infusion is given by your healthcare provider through a vein in your arm.

ORENCIA IV is approved for patients 6 years and older.

ORENCIA IV has not been studied in children under the age of 6.

OR

ORENCIA subcutaneous (SC) injection is a shot that is given just under your skin. It is available as a prefilled syringe or a ClickJect™ Autoinjector.

ORENCIA SC prefilled syringe is available for patients 2 years and older.

ORENCIA ClickJect™ Autoinjector has not been studied in children under 18 years of age.

Talk to your rheumatologist about the best way for you or your child to receive ORENCIA.

What should I discuss with my rheumatologist before starting ORENCIA?

Talk to your rheumatologist about all of your medical conditions, including if:

You have any kind of infection, as you may have a higher chance of getting serious side effects from an infection while taking ORENCIA. Infections include:

Small infections (such as an open cut or sore) to whole body infections (such as the flu).

Any infection that will not go away or a history of infections that keep coming back.

Viral hepatitis, a viral infection that affects the liver. Tell your rheumatologist if you have or have ever had viral hepatitis. Before starting ORENCIA, your rheumatologist may examine you for hepatitis.

Tuberculosis (TB), a type of lung infection. Tell your rheumatologist if you have ever had TB or a positive skin test for TB, or have recently been in close contact with someone who has ever had TB. Before starting ORENCIA, your rheumatologist may check you for TB or do a skin test. Call your rheumatologist if you notice any symptoms of TB, including: a cough that does not go away, weight loss, fever, or night sweats.

You have allergies to the ingredients of ORENCIA. For a list of ingredients, see What are the ingredients in ORENCIA? in the Patient Information section of the Full Prescribing Information.

You have Chronic Obstructive Pulmonary Disease (COPD), a type of lung disease.

You have diabetes. Your healthcare provider may tell you to use a different way to monitor your blood sugar levels on the day that you receive ORENCIA IV infusion. ORENCIA IV contains maltose, which can alter the blood sugar readings with certain types of blood glucose monitors.

Tell your rheumatologist about all of your medical treatments, including if:

You are scheduled to have surgery.

You recently received or are scheduled to receive vaccinations.

You are taking:

Other medications for RA, JIA, or PsA.

Prescription medications or over-the-counter medications.

Vitamins or herbal supplements.

Let your rheumatologist know if you are a woman who is:

Pregnant or considering pregnancy. It is not known if ORENCIA can harm an unborn baby. If ORENCIA is taken during pregnancy, talk to your healthcare provider before your baby receives any vaccines.

Breastfeeding or planning to breastfeed. It is not known if ORENCIA passes into breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ORENCIA.

What should I avoid while I am on ORENCIA?

ORENCIA and other medicines may affect each other, which could cause serious side effects. You should avoid taking ORENCIA with other biologics that may affect your immune system. Doing so may increase your chances of getting a serious infection.

Tell your rheumatologist if you are taking other biologic medicines, such as:

Enbrel® (etanercept)

Rituxan® (rituximab)

Humira® (adalimumab)

Simponi® (golimumab)

Remicade® (infliximab)

Cimzia® (certolizumab pegol)

Kineret® (anakinra)

Actemra® (tocilizumab)

Enbrel® (etanercept)

Humira® (adalimumab)

Remicade® (infliximab)

Kineret® (anakinra)

Rituxan® (rituximab)

Simponi® (golimumab)

Cimzia® (certolizumab pegol)

Actemra® (tocilizumab)

Talk to your rheumatologist and your other healthcare providers before you begin to take anything new or if you have any changes to your medications during your treatment with ORENCIA. It is a good idea to keep an up-to-date list of all of your medicines, vitamins, and herbal supplements on hand to show your doctors and pharmacists.

What are the possible side effects of ORENCIA?

This is a list of some of the possible side effects of ORENCIA for your reference.

Talk to your rheumatologist about any side effect that may be bothering you. Your rheumatologist can work with you to manage side effects throughout your treatment.

Serious side effects
Serious side effects are those that may require medical treatment or hospitalization, cause permanent damage, or be life-threatening or sometimes even fatal. Talk to your healthcare provider about any concerns you may have.

Infections. ORENCIA can make you more likely to get infections or make the infections that you have worse. In some cases, these infections have been fatal. Symptoms of an infection include:

Fever

Cough

Warm, red, or painful skin

Feeling very tired

Flu-like symptoms

Call your healthcare provider right away if you feel sick or have any of the symptoms of an infection.

Allergic reactions. Allergic reactions can happen with ORENCIA. Symptoms of an allergic reaction may include:

Hives

Swollen face, eyelids, lips, or tongue

Trouble breathing

Seek urgent medical attention if you have any of the symptoms of an allergic reaction.

If you have the hepatitis B virus, talk to your healthcare provider as hepatitis B can become an active infection while you use ORENCIA. Your rheumatologist may do blood tests before treatment with ORENCIA to check if you have hepatitis B.

If you are receiving or are scheduled to receivevaccinations, it is important to know that:

You should not receive live vaccines while taking ORENCIA and for 3 months after ending treatment, as it may cause serious side effects.

ORENCIA may also cause some other vaccinations to be less effective.

Talk to your rheumatologist about your vaccination plans.

If you have Chronic Obstructive Pulmonary Disease (COPD), you may experience breathing problems more often while taking ORENCIA. Call your healthcare provider if you experience any of the following:

Worsened COPD

Cough

Trouble breathing

Certain kinds ofcancer (malignancies) have been reported in people using ORENCIA. It is not known if ORENCIA increases your chances of developing certain kinds of cancer.

Most common side effects
The most common side effects of ORENCIA include:

Headache

Upper respiratory tract infection

Sore throat

Nausea

In children and adolescents, other side effects may include:

Diarrhea

Cough

Fever

Abdominal pain

These are not all of the possible side effects of ORENCIA. If you have any questions or want more information about side effects, ask your rheumatologist or healthcare provider.

If you experience any side effects and would like to report them to the FDA, you can call 1-800-FDA-1088.

How will I receive ORENCIA?

ORENCIA is available in two forms, as intravenous (IV) infusions and as subcutaneous (SC) injections. Work with your rheumatologist to determine the right treatment plan for you or your child.

ORENCIA IV infusion is given by a healthcare provider through a vein in your arm.

ORENCIA IV is approved for children 6 years and older.

ORENCIA IV has not been studied in children under the age of 6.

You will receive your first three infusions 2 weeks apart from each other (Weeks 0, 2, and 4). After that, you will receive an infusion every 4 weeks.

Each infusion takes about 30 minutes, though actual time in the clinic will be longer.

ORENCIA SC injection is a shot that is given just under your skin. It is available as a prefilled syringe or ClickJect™ Autoinjector.

ORENCIA SC prefilled syringe is available for patients 2 years and older.

ORENCIA ClickJect™ Autoinjector has not been studied in children under 18 years of age.

If your rheumatologist decides that your injections can be given at home, you or your caregiver will receive training on how to prepare and inject ORENCIA. Do not try to inject ORENCIA until you have been shown the right way by your rheumatologist or healthcare provider.

You will use ORENCIA SC injection once weekly.

For more information about preparing and giving ORENCIA SC injections at home, see Instructions for Use in the Patient Information section of the Full Prescribing Information.Please talk to your healthcare provider about the best way to receive ORENCIA.

*Live chat is available 8 AM to midnight EST. ORENCIA Care Counselors are available 24/7 at 1-800-ORENCIA(1-800-673-6242). ORENCIA nurses are available for assistance Monday through Friday, 8 AM to 8 PM EST. At all other times, nurses will usually return your calls within 30 to 60 minutes. Response times may vary in Puerto Rico.

†Care Counselors and nurse support can provide general information about ORENCIA, but may not provide medical advice. Your doctor is the best source of information about your health.

Selected Important Facts About ORENCIA® (abatacept)

ORENCIA can cause serious side effects, including serious infections, allergic reactions, hepatitis B infection in carriers of the virus, interactions with vaccines, respiratory problems with chronic obstructive pulmonary disease (COPD), and cancer. Side effects of ORENCIA which are considered common include: headache, upper respiratory tract infection, sore throat, and nausea. Other side effects in children and adolescents include diarrhea, cough, fever, and abdominal pain.

This is not a complete list of all side effects with ORENCIA. Tell your healthcare provider if you have any side effects while taking ORENCIA. For more information, please read the Important Facts throughout this website.

ORENCIA is a registered trademark of Bristol-Myers Squibb Company. ORENCIA On Call, ClickJect, the ORENCIA Co-pay Program, Access Support, and related logos are trademarks of Bristol-Myers Squibb Company. All other trademarks are the property of their respective owners.

427US1800793-01-01 Jul/18

Terms and Conditions for the ORENCIA® (abatacept) Co-pay Program for Self-injection

• Patients must have commercial insurance that pays for ORENCIA but does not cover the full cost; that is, you must have a co-pay obligation. Co-pay assistance is not available if your out-of-pocket expenses are $5 or less.

• Patients who have prescription insurance coverage through a state or federal healthcare program, including Medicare, Medicare Part D, Medicare Advantage, Medicaid, Tricare, Veterans Affairs (VA), or Department of Defense (DoD) programs, are not eligible for this program; patients who move from commercial to federal health insurance will no longer be eligible.

• Patients who purchased their prescription drug insurance through a Health Insurance Exchange (also known as a Health Insurance Marketplace or Small Business Health Options Program (SHOP) Marketplace) are currently eligible.

• Patients or their guardian must be 18 years of age or older.

• The ORENCIA Co-pay Assistance Card must be presented at the pharmacy, along with a valid prescription for ORENCIA, at the time of purchase.

• The Co-pay Assistance Card benefit includes 12 uses per calendar year, up to a maximum benefit of $15,000.

• The Co-pay Card must be activated before use, and expires on December 31, 2019.

• Program payments are for the benefit of the patient only.

• Patients, guardians, pharmacists, and healthcare prescribers cannot seek reimbursement from health insurance or any third party, for any part of the benefit received by the patient through this offer.

• Your acceptance of this offer confirms that this offer is consistent with your insurance and that you will report the value received as may be required by your insurance provider.

• Offer valid only in the United States and Puerto Rico; void where prohibited by law, taxed or restricted.

• Absent a change in Massachusetts law, effective July 1, 2019, Massachusetts residents will no longer be able to participate in this Program.

• The Co-pay Card is not transferable and is limited to 1 per patient. This offer may not be combined with any other rebate/coupon, free trial or similar offer.

• The Co-pay Card may not be sold, purchased, traded or counterfeited. Reproductions of the Co-pay Card are void.

• No membership fees.

• This offer is not conditioned on any past, present or future purchase, including refills.

•The ORENCIA Co-pay Assistance Card is not insurance.

• BMS reserves the right to modify or terminate this offer at any time without notice.

You are now leaving this Bristol-Myers Squibb site.

This Internet site may provide links or references to other sites. Bristol-Myers Squibb has no responsibility for the content of such other sites and is not liable for any damages or injury arising from that content. Any links to other sites are provided merely as a convenience to the users of this Internet site.

You are about to leave this Bristol-Myers Squibb
Company site. You are being redirected to another
Bristol-Myers Squibb Company site.

You are about to leave this Bristol-Myers Squibb Company site. You are being redirected to another Bristol-Myers Squibb Company site.

This Internet site may provide links or references to other sites. Bristol-Myers Squibb has no responsibility for the content of such other sites and is not liable for any damages or injury arising from that content. Any links to other sites are provided merely as a convenience to the users of this Internet site.

You are about to leave this Bristol-Myers Squibb Company site. You are being redirected to another Bristol-Myers Squibb Company site.

This Internet site may provide links or references to other sites. Bristol-Myers Squibb has no responsibility for the content of such other sites and is not liable for any damages or injury arising from that content. Any links to other sites are provided merely as a convenience to the users of this Internet site.
Would you like to leave this site?

You are about to leave this Bristol-Myers Squibb Company site. You are being redirected to another Bristol-Myers Squibb Company site.

This Internet site may provide links or references to other sites. Bristol-Myers Squibb has no responsibility for the content of such other sites and is not liable for any damages or injury arising from that content. Any links to other sites are provided merely as a convenience to the users of this Internet site.